Clinical Research Coordinator B Position
4 days ago
The University of Pennsylvania seeks a highly skilled Clinical Research Coordinator B to join our team. As a Clinical Research Coordinator B, you will play a critical role in the conduct of clinical trials, ensuring the highest standards of quality and compliance.
Key Responsibilities:
- Prepare and process Institutional Review Board (IRB) submissions, including initial submissions, amendments, continuing reviews, adverse events, and serious adverse events.
- Coordinate, organize, and maintain all documentation required by sponsors or Contract Research Organizations (CROs), including case report forms, source documentation, study and regulatory binders, and subject binders.
- Assist in the coordination of Phase I-IV clinical trials, including scheduling patient visits and necessary testing.
- Participate in study audits by sponsors, CROs, the FDA, and other entities as required.
- Ensure proper screening and enrollment of all study participants, including administering informed consent and confirming subject study eligibility prior to participation.
- Ensure proper reporting of serious and non-serious adverse events to the Sponsor and all applicable institutional or study-related committees and personnel.
Requirements:
- Bachelor of Science degree and 2-3 years of experience or equivalent combination of education and experience.
- Strong knowledge of clinical research principles, regulations, and guidelines.
- Excellent organizational, communication, and interpersonal skills.
- Ability to work independently and as part of a team.
What We Offer:
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- A dynamic and supportive work environment.
How to Apply:
Interested candidates should submit their application, including a cover letter and resume, to [insert contact information].
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